BLA 125545

HOSPIRA INC

FDA Drug Application

Application #125545

Documents

• Label: 2018-05-15
• Medication Guide: 2018-05-15
• Letter: 2018-05-15
• Review: 2018-12-13
• Label: 2019-01-22
• Medication Guide: 2019-01-22
• Letter: 2019-01-22
• Label: 2020-07-01
• Medication Guide: 2020-07-01
• Letter: 2020-07-01

Application Sponsors

BLA 125545

HOSPIRA INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	INJECTABLE;INJECTION	2,000UNITS/ML	0	RETACRIT	EPOETIN ALFA-EPBX
002	INJECTABLE;INJECTION	3,000UNITS/ML	0	RETACRIT	EPOETIN ALFA-EPBX
003	INJECTABLE;INJECTION	4,000UNITS/ML	0	RETACRIT	EPOETIN ALFA-EPBX
004	INJECTABLE;INJECTION	10,000UNITS/ML	0	RETACRIT	EPOETIN ALFA-EPBX
005	INJECTABLE;INJECTION	40,000UNITS/ML	0	RETACRIT	EPOETIN ALFA-EPBX

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2018-05-15	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-01-18	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2020-06-30	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7
SUPPL	5	Null	15

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125545
            [companyName] => HOSPIRA INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/125545s005lbl.pdf#page=31"]
            [products] => [{"drugName":"RETACRIT","activeIngredients":"EPOETIN ALFA-EPBX","strength":"2,000UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"RETACRIT","activeIngredients":"EPOETIN ALFA-EPBX","strength":"3,000UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"RETACRIT","activeIngredients":"EPOETIN ALFA-EPBX","strength":"4,000UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"RETACRIT","activeIngredients":"EPOETIN ALFA-EPBX","strength":"10,000UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"RETACRIT","activeIngredients":"EPOETIN ALFA-EPBX","strength":"40,000UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/30\/2020","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125545s005lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125545s003lbl.pdf\"}]","notes":""},{"actionDate":"05\/15\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125545s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/15\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125545s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125545Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/125545Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/30\/2020","submission":"SUPPL-5","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125545s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125545Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"01\/18\/2019","submission":"SUPPL-3","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125545s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125545Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-06-30
        )

)